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Description

Responsible and accountable for supporting and managing document control activities including but not limited to: document coordinator activities, logbook management, cGMP document archival, batch record issuance and training management system. Subject matter expert for related technical and compliance information within the Quality unit. The Specialist level position may assist leadership in their absence. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

+ Manage and file all controlled GMP documentation in compliance with internal procedures and policies, as well as, regulatory requirements.

+ Establishes and is accountable for maintaining the archival, retrieval, retention and destruction of controlled documentation.

+ Responsible for the issuance, archiving and control of Log Books and/or laboratory notebooks for use in production.

+ Responsible for preparing production records per the production schedule(s).

+ Provide second check verification of records prior to issuance to production as required.

+ Assist with training of new employees on issuance of records.

+ Assist with inspection readiness and preparation activities as required by management.

+ As needed, audit preparation for regulatory agency audits/customer inspections.

+ Identify Quality System process initiatives for optimization and compliance.

+ Lead and execute improvement plans within area of responsibility.

+ Projects:

+ Actively participates on project teams as assigned by supervisor

+ Coordinates and leads projects with supervision.

+ Coordinates and leads projects within group without supervision.

+ Resolves issues found during documentation review (documentation errors, missing information) as directed by SOP.

+ Assists QA management with the development of training plans within department and trains others.

+ Deviations/CAPA:

+ Initiates deviations in Quality electronic systems when required.

+ Writes or participates in deviation investigations for determination of appropriate root causes.

+ Performs follow-up on CAPAs for completion.

+ Adherence to compliance and regulatory requirements.

+ Demonstrated high ethical and professional standards with all business contacts in order to maintain the site's excellent reputation in the community.

Requirements

+ Bachelor's degree from an accredited institution in Business, Science or related field.

+ Alongside bachelor's degree, a minimum of two (2) years relevant Quality Assurance experience in a cGMP manufacturing or similar environment.

+ In lieu of degree, at minimum of five (5) years relevant Quality Assurance experience in a cGMP manufacturing or similar environment.

+ Demonstrated written and verbal communication, organization and teamwork skills.

+ Sound decision making skills along with ability to take quick actions.

+ Excellent attention to detail with an ability to be self-directed while managing projects and assigned accountabilities.

+ Ability to utilize computer programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source, TrackWise and other relevant electronic applications.

+ Influencing the understanding of GMP's, compliance requirements, and regulatory requirements to assess product, procedures, and recommend improvements to quality culture.

+ Shares technical and compliance knowledge horizontally and vertically across the site.

+ High level of demonstrated technical competence, communication, integrity/ethics and analytical thinking.

Eligibility Requirements

Must be legally authorized to work in the United States without restriction.

Must be willing to take a drug test and post-offer physical (if required).

Must be 18 years of age or older.

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.